FDA Adverse Event
Injury
Summary report: N
ANCHOR FAST ORAL ENDOTRACHEAL TUBE FASTENER # 9799
MDR report key: 2994285
·
Received March 1, 2013
Report
- Report Number
- MW5029239
- Event Type
- Injury
- Date Received
- March 1, 2013
- Date of Event
- February 28, 2013
- Report Date
- March 1, 2013
- Manufacturer
- HOLLISTER, INC.
- Product Code
- CBH
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
(B)(6) WITH COMPLICATED MEDICAL/SURGICAL COURSE, S/P HEMICOLECTOMY FOR VOLVULUS WAS EXTUBATED ON (B)(6) - INTUBATED (B)(6). ABOUT 15 MINUTES AFTER EXTUBATION, HE DEVELOPED STRIDOR AND REQUIRED REINTUBATION. ANESTHESIA USED A GLIDESCOPE AS A DIFFICULT INTUBATION WAS ANTICIPATED. THE FOAM BUMPER FROM THE ETT FASTENER WAS NOTED IN THE PATIENT'S UPPER AIRWAY AND WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 89456 | ANCHOR FAST ORAL ENDOTRACHEAL TUBE FASTENER # 9799 | ORAL ETT FASTENER | CBH | HOLLISTER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |